MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLAIR ENDOVASCULAR STENT GRAFT

Model Number	FAF08050
Medical Device Problem Codes	Fracture (1260); Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical records were not provided; however, medical images were provided and are currently being reviewed.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that approximately post one week of the endovascular stent graft placement procedure in the venous anastomosis via the left upper arm an alleged occlusion and stent graft fracture were identified under guided fluoroscopy.Therefore, medical intervention was required; a second stent was deployed within the first deployed stent, via the same access.The patient was hemodynamically stable at the conclusion of the procedure.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned.One x-ray image was provided.Based on the image review vascular stent fracture was inconclusive due to poor image quality.Occlusion within the device was also inconclusive as the device was not returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the current ifu (instructions for use) states: stent graft size selection: special care must be taken to ensure that the appropriate size flair endovascular stent graft is selected.The stent graft body diameter should be approximately 1 mm larger than the synthetic av access graft diameter.The distal end of the flared configuration devices are approximately 4 mm larger in diameter than the body section.Precautions: faulty placement techniques may lead to failure in stent graft deployment.Do not kink the delivery system.The delivery system can function only after the red safety clip has been pulled off and the tuohy-borst valve is loosened.This should not be done until the stent graft is positioned across the lesion and is ready to be deployed.The safety and effectiveness of this device have not been established when used around a tight bend in a looped av graft.It is recommended to access the av graft at the venous side of the av graft or at the apex.Potential complications and adverse events: delivery system specific events that could be associated with clinical complications include bond joint failures, detachment of parts, incompatibility with accessory devices, premature deployment, inaccurate deployment, failure to deploy, high deployment forces, delivery system kinking, no visibility under fluoroscopy, inability to track to target location, and blood leakage from delivery system (hemostasis).Directions for use: after full stent graft deployment, wait a few seconds to allow for complete device expansion before removing the delivery system over the guidewire.If resistance is felt in passing the introducer sheath, the flexible deployment system should be removed together with the introducer sheath.Visually confirm that the complete system has been removed.Inner catheter.Distal tip.Outer sheath.Radiopaque marker band on outer sheath.Distal radiopaque marker band on inner catheter.Proximal radiopaque marker band on inner catheter.
Event or Problem Description
It was reported that approximately post one week of the endovascular stent graft placement procedure in the venous anastomosis via the left upper arm an alleged occlusion and stent graft fracture were identified under guided fluoroscopy.Therefore, medical intervention was required; a second stent was deployed within the first deployed stent, via the same access.The patient was hemodynamically stable at the conclusion of the procedure.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6868853
• Report Number: 2020394-2017-01152
• Device Sequence Number: 1895958
• Product Code: PFV
• UDI-Device Identifier: 04049519008837
• UDI-Public: (01)04049519008837
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2020
• Device Model Number: FAF08050
• Device Catalogue Number: FAF08050
• Device Lot Number: ANBT0886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 82